CTRI/2015/05/005783已完成3 期
A Multicentric, Double Blind, Randomized, Active Control, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of 2% Rebamipide Ophthalmic Suspension Vs. 0.1 % Sodium Hyaluronate Ophthalmic solution for treatment of patients with Dry Eye.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.A clinical diagnosis Dry Eye at least since from 20 months.
- •2.Anesthetized Schirmer test score of 0 to 9 mm per 5minutes or less or tear breakup time is 5 seconds or less.
- •3.Best corrected visual acuity of 0.2 or better in both eyes.
- •4.Voluntary willingness to give written informed consent prior to participation in trial.
- •5.Wash out period for subjects who are on medications for same condition will be 3 days.
排除标准
- •1.Any active inflammation of eyes.
- •2.Any long lasting inflammation of eyes.
- •3.Subject with block nasal duct.
- •4.Subjects with history of recurrent corneal erosions diagnosed by slit lamp examination.
- •5.Subjects with history of epithelial basement membrane dystrophy.
- •6.Subjects with history of floppy eyelid syndrome diagnosed by Slit lamp examination
- •7.Subjects with history of Conjunctivochalasis diagnosed by slit lamp examination
- •8.Anterior segment disease like Glaucoma or Ocular Hypertension.
- •9.Using Cyclosporine since long time
- •10.Use of contact lenses
- •11.Use of topically instilled Ocular medication during study.
- •12.History of Ocular surgery within 12 months.
- •13.Females who are pregnant, lactating, or child bearing potential.
- •14.Females who are not willing to remain abstinent or use contraception.
- •15.Subjects who are on systemic Hormonal or corticosteroid therapy.
- •16.Subjects with history of Diabetes Mellitus.
- •17.Presence of Stevens Johnson Syndrome.
- •18.Ocular surgery due to Dry eye Syndrome.
- •19.Use of topical &/or systemic treatment potentially interfering with tear production.
- •20.Concurrent involvement in another study or previous receipt of same drug.
- •21.Any ocular condition that, in the opinion of the investigator, could affect the subjectâ??s safety or trial parameters.
- •22.Known contraindications or sensitivities to the study medication or its components.
- •23.Other patients who are in the opinion of the investigator/sub investigator were inappropriate for the study participation.
研究者
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